The U.S. Food and Drug Administration (FDA) has authorized the emergency use of the investigational product Pfizer-BioNTech COVID-19 Vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) in individuals 12 years of age and older. The vaccine has not been approved, but is authorized under an Emergency Use Authorization only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the vaccine under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.